Enzalutamide (Xtandi)
Androgen receptor inhibitor for castration-resistant and castration-sensitive prostate cancer.
What is Enzalutamide?
What it targets
Androgen receptor (AR) pathway
Who it may help
Selected patients with castration-resistant or castration-sensitive prostate cancer
Why testing matters
PSA level, testosterone, imaging, and safety review
Which prostate cancer settings can Enzalutamide treat?
Enzalutamide is approved across several prostate cancer disease settings. Your oncologist determines which setting applies based on PSA trends, testosterone level, imaging, and prior therapy.
| Metastatic castration-resistant prostate cancer (mCRPC) | Used when prostate cancer has spread and continues to grow despite testosterone suppression. Can be used before or after chemotherapy depending on clinical history. |
| Non-metastatic castration-resistant prostate cancer (nmCRPC) | Used when PSA is rising despite testosterone suppression but imaging does not show distant metastases. Delays time to first metastasis in eligible patients. |
| Metastatic castration-sensitive prostate cancer (mCSPC) | FDA-approved for use with androgen deprivation therapy in patients with hormone-sensitive metastatic disease. NMPA approved this indication in China in 2024. |
| Non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence | FDA-approved in this setting in the United States for patients with PSA recurrence after local therapy and no visible metastases on conventional imaging. |
Who may benefit from Enzalutamide?
Your oncologist determines eligibility based on disease setting, PSA trend, testosterone level, metastatic status, prior treatments, and safety factors.
- Patients with confirmed metastatic castration-resistant prostate cancer (mCRPC) with or without prior chemotherapy.
- Patients with non-metastatic CRPC and a rapidly rising PSA (short PSA doubling time).
- Patients with metastatic hormone-sensitive prostate cancer where Enzalutamide is locally approved with ADT.
- Patients already receiving medical or surgical testosterone suppression as required by the label for most settings.
- Patients with adequate performance status, organ function, and no uncontrolled seizure risk.
- Patients without significant drug interactions that cannot be managed or substituted.
- Patients in high-risk biochemical recurrence after local therapy, per FDA labelling in that specific setting.
- Patients fit enough for oral once-daily therapy and regular PSA and imaging monitoring.
How does Enzalutamide work?
- Prostate cancer and androgen dependence
- Blocking the androgen receptor
- Slowing cancer growth
- No chemotherapy mechanism
Tests needed before starting Enzalutamide
Your oncology team will request baseline tests to confirm eligibility, assess safety, and establish monitoring benchmarks.
| PSA test | Baseline PSA level and trend (PSA doubling time) used to assess response and guide monitoring. |
| Serum testosterone | Confirms castrate range in CRPC settings where ongoing testosterone suppression is required. |
| Imaging (CT, MRI, bone scan, PSMA PET) | Confirms metastatic status and determines correct disease setting for treatment planning. |
| Complete blood count (CBC) | Baseline blood counts before treatment; anaemia or cytopenias reviewed. |
| Liver and kidney function tests | Enzalutamide is metabolised hepatically; baseline liver function required. Kidney function for dose safety. |
| Cardiovascular and blood pressure review | High blood pressure is a recognised risk; cardiovascular history reviewed before starting. |
| Seizure and falls risk review | Prior seizure, brain injury, neurological conditions, or fall history assessed before starting. |
| Full medication review | CYP3A4/2C8/2C19 interactions with existing medicines, supplements, and herbal products checked. |
How is Enzalutamide given?
Enzalutamide is an oral medicine taken at home once daily. The dose and formulation (capsule or tablet) are decided by the oncologist based on the available product and patient circumstances.
| Standard dose — most indications | 160 mg once daily (four 40 mg capsules, or one 160 mg tablet depending on formulation available). |
| Dose reduction | Dose may be reduced to 120 mg or 80 mg once daily if side effects such as seizure risk or significant toxicity occur, per oncologist decision. |
| How to take | Taken by mouth with or without food. Swallow capsules or tablets whole — do not crush, chew, or open. |
| Timing | Take at the same time each day to maintain consistent blood levels. A consistent daily routine helps with adherence. |
| Missed dose | Take the missed dose on the same day as soon as remembered. If it is the next day, skip the missed dose and resume the normal schedule — do not double the dose. |
| Duration | Treatment continues until disease progression, unacceptable side effects, or until the oncologist advises a change in treatment plan. Do not stop without medical advice. |
Clinical evidence and potential benefits
Enzalutamide has been studied in multiple large randomised trials across CRPC and mCSPC settings. Benefits vary by disease stage, prior treatments, and individual patient factors.
| Metastatic CRPC — PREVAIL trial | In chemotherapy-naive mCRPC, Enzalutamide significantly reduced risk of radiographic progression and delayed the need for chemotherapy versus placebo. |
| Metastatic CRPC — AFFIRM trial | In post-docetaxel mCRPC, Enzalutamide significantly improved overall survival compared with placebo in patients who had progressed after chemotherapy. |
| Non-metastatic CRPC — PROSPER trial | In nmCRPC, Enzalutamide substantially prolonged metastasis-free survival versus placebo in patients with rising PSA on ADT. |
| Metastatic castration-sensitive prostate cancer — ARCHES and ENZAMET trials | When added to androgen deprivation therapy in mCSPC, Enzalutamide significantly reduced risk of radiographic progression and improved survival outcomes. |
| PSA response | Substantial PSA reductions are observed in many patients, providing a measurable indicator of treatment activity. |
| Oral convenience | Once-daily oral tablet or capsule taken at home avoids the need for hospital infusions, supporting quality of life and independence during treatment. |
Individual responses vary. These represent published clinical trial data. Benefits must be weighed against risks by your oncologist.
Side effects of Enzalutamide
Enzalutamide is a hormone therapy, not chemotherapy. Side effects differ from chemotherapy — fatigue, hot flashes, and falls risk are more typical than nausea or hair loss. Most side effects are manageable with monitoring.
| Fatigue | Common — reported by many patients. Can range from mild tiredness to significant weakness. Light activity, regular rest, and review by the oncology team help. |
| Hot flashes | Common in patients on androgen deprivation therapy; Enzalutamide may worsen or continue this effect. |
| High blood pressure | Recognised risk — blood pressure is monitored regularly. May require antihypertensive medicine; report significant headaches or readings to your team. |
| Falls and dizziness | Balance problems and dizziness can increase falls risk, particularly in older patients. Review home safety and avoid activities requiring sharp alertness if dizziness is present. |
| Joint and muscle pain | Musculoskeletal aches reported by a significant proportion of patients. Report persistent or worsening pain to your oncologist. |
| Cognitive effects | Some patients notice memory difficulties, concentration problems, or mental fog — particularly older patients. Discuss promptly if affecting daily life. |
| Headache | Mild to moderate headaches reported. Persistent or severe headaches warrant prompt medical review. |
| Loss of appetite and weight changes | Appetite reduction and weight change can occur; nutrition support may be helpful in affected patients. |
| Seizures (rare but serious) | Enzalutamide lowers the seizure threshold. Incidence is low in patients without risk factors but higher in those with prior neurological conditions. |
| Posterior reversible encephalopathy syndrome (PRES) | Rare but serious — symptoms include confusion, vision changes, and severe headache. Requires urgent medical assessment. |
Contact your doctor immediately if you develop:
- Seizure or convulsion of any kind, or loss of consciousness.
- Sudden severe headache, vision changes, or confusion — possible PRES.
- Chest pain, rapid or irregular heartbeat, or fainting.
- Severe falls, fractures, or inability to stand safely.
- Swelling of the face, lips, or throat, or difficulty breathing.
- Severe weakness, new neurological symptoms, or sudden change in balance.
Safety precautions and drug interactions
Tell your oncologist and pharmacist about all medicines, supplements, and herbal products before starting Enzalutamide. Drug interactions are clinically significant.
- Enzalutamide is a strong CYP3A4 inducer and moderate CYP2C8 and CYP2C19 inducer, reducing blood levels of many commonly prescribed drugs.
- Warfarin levels can be significantly reduced — patients on warfarin may need switching to an alternative anticoagulant.
- Antifungals (itraconazole, fluconazole), antivirals, and some antibiotics can alter Enzalutamide levels or be altered by it.
- Avoid St John's Wort — this herbal product reduces Enzalutamide plasma levels and can reduce treatment effectiveness.
- Disclose any prior seizure disorder, brain injury, brain tumour, stroke, or neurological condition.
- Disclose history of falls, fractures, or balance problems — Enzalutamide increases falls and fracture risk.
- Enzalutamide can harm a developing foetus. Patients with reproductive potential or partners of childbearing potential must use effective contraception during and after treatment.
- Do not use Enzalutamide in patients who are pregnant or in patients with female partners who are pregnant.
- Inform your dentist and any surgeon about Enzalutamide before procedures, as bone health and healing may be affected.
Enzalutamide combination treatments
Enzalutamide is most commonly used with androgen deprivation therapy. Other combinations are used in specific clinical settings or clinical trials.
| Enzalutamide + GnRH agonist or antagonist (ADT) | Standard combination in metastatic CRPC and mCSPC. ADT maintains testosterone at castrate levels while Enzalutamide blocks the androgen receptor. |
| Enzalutamide + radiation therapy | Studied in selected localised and locally advanced prostate cancer settings; used in combination with radiotherapy in certain clinical situations per oncologist decision. |
| Enzalutamide + PARP inhibitor | Combination trials with PARP inhibitors (olaparib, talazoparib) have been studied in CRPC with or without DNA repair mutations; availability and approval vary by country. |
| Bone-protective agents | Denosumab or bisphosphonates may be added in patients with bone metastases or osteoporosis risk from ongoing androgen suppression. |
| Supportive care alongside treatment | Medicines for bone pain, fatigue, hypertension, urinary symptoms, and nutritional support are frequently used alongside Enzalutamide. |
If Enzalutamide stops working
Resistance to Enzalutamide can develop through several mechanisms. When PSA rises or imaging shows progression, the oncology team will reassess and plan next steps.
| Androgen receptor amplification or mutation | Mutations in the ligand-binding domain (such as AR-V7 splice variant) can render Enzalutamide ineffective. AR-V7 testing by liquid biopsy may guide next treatment choice. |
| Lineage plasticity and neuroendocrine differentiation | Some tumours transform to androgen receptor-independent growth, including neuroendocrine prostate cancer, which requires different treatment strategies. |
| Repeat PSA and imaging assessment | PSA trend alone does not confirm progression — CT, bone scan, and PSMA PET are repeated to confirm and characterise disease progression before changing treatment. |
| Next-line systemic options | After Enzalutamide, options may include docetaxel, cabazitaxel, lutetium-177 PSMA therapy (for PSMA-positive disease), PARP inhibitors (for BRCA/HRR mutations), or clinical trials. |
| Molecular and biomarker testing at progression | Liquid biopsy, tissue re-biopsy, or next-generation sequencing may identify actionable alterations such as BRCA1/2, CDK12, or mismatch repair deficiency. |
| Second opinion | A specialist second opinion at progression can identify newer options, trials, or access pathways in India, China, or internationally that may not be locally available. |
Cost of Enzalutamide by country
Branded Xtandi is expensive in most markets; generic enzalutamide is becoming available in some countries, significantly reducing cost. Total treatment cost includes monitoring and ADT.
| India | Generic enzalutamide is available in India at a fraction of the branded price; exact cost varies by manufacturer and pharmacy. Branded Xtandi is also available at a higher price point. CancerFax can help identify legitimate access options. |
| USA | Branded Xtandi carries a high monthly cost. Patient assistance programmes from Astellas (Xtandi Access Services) may reduce cost for eligible patients. Generic availability is expanding. |
| UK / Europe | NHS and national health systems in several European countries cover Enzalutamide for approved indications. Self-pay cost for branded Xtandi is high; generic access is growing. |
| China | NMPA-approved Xtandi is available in China. It has been added to the National Reimbursement Drug List (NRDL), which substantially reduces patient cost in covered settings. |
| UAE / Gulf | Branded Xtandi is available in major oncology centres; insurance coverage varies. Cost is typically between India and Western market prices. |
| Additional treatment costs | Total cost includes ADT injections, PSA testing, imaging (CT, bone scan, PSMA PET), bone health medicines, blood pressure monitoring, and management of side effects. |
Availability of Enzalutamide globally
Enzalutamide (Xtandi) is approved by the FDA, EMA, and NMPA. It is available in most major oncology markets. Generic versions are available in selected markets.
India
Generic enzalutamide is available in India through oncology pharmacies. Branded Xtandi is also importable. CancerFax can help identify legitimate sourcing options for patients in India and internationally.
China
Xtandi is NMPA-approved for mCRPC, nmCRPC, and mCSPC (approved 2024 for mCSPC). It is on the National Reimbursement Drug List, reducing patient cost in covered settings.
USA
FDA-approved for mCRPC, nmCRPC, mCSPC, and nmCSPC with high-risk biochemical recurrence. Available at major pharmacy chains. Patient assistance programmes available through Astellas.
UK / Europe
EMA-approved Xtandi is available across Europe. NHS-funded in England for approved prostate cancer indications. National insurance coverage varies across EU member states.
UAE / Gulf
Branded Xtandi available at major oncology hospitals in the UAE and Gulf region. Insurance coverage varies by provider and indication. Discuss cost with your treatment centre.
Enzalutamide in current clinical trials
Enzalutamide continues to be studied in earlier disease settings, novel combinations, and biomarker-selected populations to further optimise its use in prostate cancer.
| Earlier disease and biochemical recurrence | Trials evaluating Enzalutamide in localised high-risk prostate cancer, post-radiotherapy biochemical recurrence, and non-metastatic hormone-sensitive settings. |
| Combination with PARP inhibitors | Studies of Enzalutamide with olaparib and talazoparib in unselected and biomarker-selected (HRR mutation) mCRPC populations — some combinations now have regulatory approvals in selected indications. |
| Combination with novel ADT agents | Trials combining Enzalutamide with next-generation ADT (relugolix) or with androgen synthesis inhibitors to deepen androgen suppression. |
| Biomarker-selected patient populations | Ongoing efforts to identify which molecular subtypes (AR splice variants, HRR mutations, CDK12) benefit most from Enzalutamide vs. alternative AR pathway or PARP inhibitor strategies. |
| Radioligand therapy sequencing | Studies examining optimal sequencing of Enzalutamide with lutetium-177 PSMA therapy in mCRPC, and whether prior AR inhibitor use affects PSMA expression. |
Your treatment journey with Enzalutamide
Diagnosis, staging, and PSA assessment
Establishing castration-resistant or castration-sensitive status
Baseline tests and safety review
Starting Enzalutamide
Ongoing PSA and safety monitoring
Repeat imaging at clinical milestones
Next treatment decision if disease progresses
Questions to ask your oncologist about Enzalutamide
- Which disease setting do I have — metastatic, non-metastatic, CRPC, or castration-sensitive?
- Do I need to continue or start androgen deprivation therapy with Enzalutamide?
- How will we know if Enzalutamide is working?
- Do I have any seizure, falls, or cardiac risk factors that could affect my suitability?
- Will Enzalutamide interact with my other medicines?
- What is the expected monthly cost and are there generic or assistance options?
- What are my options if Enzalutamide stops working?
- Should I have genetic or molecular testing alongside Enzalutamide treatment?
How CancerFax supports Enzalutamide patients
CancerFax helps prostate cancer patients and families navigate access to Enzalutamide and connects them with oncologists experienced in advanced prostate cancer care.
| Medical report review | Upload your PSA reports, imaging, biopsy, or treatment history — our oncology team reviews and explains what they mean for Enzalutamide eligibility and treatment planning. |
| Specialist connection | We connect patients with urological oncologists and medical oncologists experienced in CRPC, mCSPC, and hormone therapy in India, China, UAE, Turkey, and internationally. |
| Second opinion | If you are uncertain about your treatment plan, disease setting, or whether Enzalutamide is the right choice, CancerFax arranges a specialist oncology second opinion. |
| Access and cost navigation | CancerFax helps patients identify generic Enzalutamide options, patient assistance programmes, and legitimate access channels in India and other markets where cost is a barrier. |
| China and international treatment options | For patients considering advanced prostate cancer care in China — including novel clinical trials, cell therapies, or radioligand access — CancerFax provides end-to-end navigation and coordination. |
| Biomarker and genetic testing guidance | We help patients understand which molecular tests are relevant in advanced prostate cancer (BRCA, HRR, AR-V7, PSMA) and how results can open access to PARP inhibitors, radioligand therapy, or immunotherapy. |
Frequently asked questions about Enzalutamide
Common questions from patients and caregivers
No, Enzalutamide is not chemotherapy. It is an androgen receptor inhibitor — a type of hormone therapy. It works by blocking the androgen receptor that prostate cancer cells depend on to grow, rather than by killing cells directly the way chemotherapy does. Most patients experience far fewer severe side effects compared with chemotherapy.
PSA levels may begin to fall within the first few weeks of treatment in patients who respond. Imaging response and symptomatic improvement may take longer — typically assessed at the first scan check-in at around 8–12 weeks. Your oncologist will set PSA and scan targets based on your specific disease setting.
Enzalutamide is a strong inducer of the liver enzyme CYP3A4 and also affects CYP2C8 and CYP2C19, meaning it can significantly reduce blood levels of many common drugs — including warfarin, certain antifungals, heart medicines, and anticonvulsants. Always bring a full medication list to every appointment and ask your pharmacist to check for interactions before starting any new medicine, including over-the-counter or herbal products.
Yes. Sorafenib is available as generic versions in several countries, including India, where it has an important history linked to the country's first compulsory licence for a cancer drug. Generic sorafenib contains the same active ingredient at the same dose and has been used widely. Ask your oncologist or pharmacist about generic availability and legitimate sourcing in your country. CancerFax can also help with access guidance across India, China, and other regions.
No. Do not stop Enzalutamide without speaking to your oncologist first. Stopping treatment abruptly without a plan can allow prostate cancer to progress rapidly. If you are experiencing side effects or cost difficulties, contact your doctor promptly so they can adjust the dose, manage side effects, or arrange alternative access — rather than stopping without guidance.
If PSA rises or imaging shows progression despite Enzalutamide, your oncologist will typically repeat blood tests and scans, check testosterone levels, and consider options such as chemotherapy (docetaxel or cabazitaxel), radioligand therapy (lutetium-177 PSMA in eligible patients), PARP inhibitors for DNA repair mutations, or a clinical trial. A second opinion can help identify newer treatment options available in India, China, or internationally.
Enzalutamide carries a known risk of seizures, even in patients with no prior seizure history. Patients who have had a prior seizure, brain injury, brain tumour, stroke, or who are taking medicines that lower the seizure threshold are at higher risk. Always disclose any neurological history to your oncologist before starting treatment. Your doctor may recommend an alternative androgen receptor inhibitor if seizure risk is significant.
In most treatment settings — including metastatic CRPC and metastatic castration-sensitive prostate cancer — Enzalutamide is used together with ongoing androgen deprivation therapy (a GnRH agonist or antagonist), or in patients who have already had surgical testosterone removal. Your oncologist will advise whether you need to continue or start ADT alongside Enzalutamide based on your specific disease setting.